跳至主要内容
临床试验/NCT07339696
NCT07339696Enrolling By Invitation不适用

DANISH TITLE: Projekt Rette hjælp Til børn Med ADHD Eller Udfordringer Med Uro og Koncentration

University of Aarhus1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年2月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
90
试验地点
1
主要终点
Primary Outcome (exploratory clinical signal): ADHD Rating Scale-IV (ADHD-RS-IV) Danish Version - parent ratings

研究概览

简要总结

The aim of this study is to devise implementation strategies for the New Forest Parenting Programme (NFPP) to support a community implementation model (NFPP-CIM) and test its feasibility and acceptability for parents and stakeholders.

详细描述

Background Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition associated with substantial individual and societal costs. Although effective behavioural interventions such as the New Forest Parenting Programme (NFPP) are available, access to evidence-based parent training remains limited in community settings. The current study addresses the gap between research and practice by supporting the implementation of NFPP within local Child and Family Services in Danish municipalities.

Purpose and Rationale The primary aim of this study is to develop and evaluate the feasibility and acceptability of a community implementation model for the New Forest Parenting Programme (NFPP-CIM). The project is designed as a Hybrid Type II feasibility study, focusing on both implementation processes and perceived effects in real-world community contexts. The study seeks to determine whether the NFPP-CIM can support feasible, acceptable, and sustainable delivery of NFPP by local practitioners, thereby informing future large-scale implementation.

Objectives

The study objectives are guided by the Expert Recommendations for Implementing Change (ERIC) framework and include:

To develop an NFPP Community Implementation Model (NFPP-CIM) tailored to Danish municipal contexts.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Families receiving services through municipal child and family clinics in Denmark
  • Child aged 3-12 years
  • Parent-perceived difficulties with attention and activity regulation, including those with a diagnosis or suspected diagnosis of ADHD.
  • All custodial parents willing and able to provide informed consent
  • Parents interested in participating in the New Forest Parenting Programme - Community Implementation Model (NFPP-CIM)

排除标准

  • Families not receiving services through municipal child and family clinics
  • Parents unable to provide informed consent
  • Families unable to participate in the intervention due to severe child or family circumstances that preclude engagement (e.g. acute crisis requiring alternative services, Parents or children with severe mental or physical illness that would prevent active participation in the intervention)

研究组 & 干预措施

NFPP-CIM Implementation Group

The group includes families with children aged 3-12 years with ADHD or attention and activity difficulties, as well as community practitioners, managers, and other local stakeholders involved in delivering the New Forest Parenting Programme - Community Implementation Model (NFPP-CIM). The study evaluates the feasibility, acceptability, and perceived outcomes of implementing NFPP-CIM in municipal child and family services.

干预措施: New Forest Parenting Programme (Behavioral)

结局指标

主要结局

Primary Outcome (exploratory clinical signal): ADHD Rating Scale-IV (ADHD-RS-IV) Danish Version - parent ratings

时间窗: Change in ADHD symptoms measured by ADHD-RS from baseline to post-intervention. I.e. From T1: enrolment (baseline) to T2: T2 (End of treatment): approximately 16 weeks after T1 to T3 (Follow-up): approximately 36 weeks after T2.

This outcome is included solely as an exploratory signal of change to inform the design of a future fully powered trial; the current study is not powered to detect statistically significant effects.The ADHD-RS is an 18-item questionnaire that addresses child symptoms of ADHD and symptoms of oppositional defiant disorder/conduct disorder on a four point scale ('not at all' to 'very often') (DuPaul, G.J., et al., Parent ratings of attention-deficit/hyperactivity disorder symptoms: Factor structure and normative data. Journal of Psychopathology and Behavioral Assessment, 1998. 20(1): p. 83-102.)

次要结局

  • The Strengths and Difficulties Questionnaire (SDQ) - Danish parent version(Change in SDQ scores from baseline (T1) at enrollment, to post-intervention (T2) approximately 16 weeks after T1, and to follow-up (T3) approximately 36 weeks after T2.)
  • The Parenting Sense of Competence Scale (PSOC) Danish version - parent ratings(Change in PSOC scores from baseline (T1) at enrollment, to post-intervention (T2) approximately 16 weeks after T1, and to follow-up (T3) approximately 36 weeks after T2.)
  • Family Strain Index (FSI) - parent ratings(Change in FSI scores from baseline (T1) at enrollment, to post-intervention (T2) approximately 16 weeks after T1, and to follow-up (T3) approximately 36 weeks after T2.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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